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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K242376
Device Name Next Generation Access Platform
Applicant
Balt USA, LLC
29, Parker
Irvine,  CA  92618
Applicant Contact Alicia Smith
Correspondent
Balt USA, LLC
29, Parker
Irvine,  CA  92618
Correspondent Contact Alicia Smith
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received08/09/2024
Decision Date 12/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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